An open label clinical trial to evaluate the efficacy of Sugralo capsule in Madhumeha (Diabetes mellitus type 2)
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in FBS
研究概览
简要总结
It is an open labeled single armed, singlecentric, prospective clinical study to evaluate the efficacy of Sugralocapsules on 50 patients suffering from Madhumeha (diagnosed for the first timeor diagnosed cases not taking any medicines for last 3 months). The study willbe conducted in Department of Panchkarma, NIA, Jaipur, Rajasthan. Sugralocapsules will be administered in a dose of 2 capsules (500 mg each) orally 30minutes before meal with lukewarm water for 90 days. The efficacy of Sugralocapsules in patients of Madhumeha (diagnosed for the first time or diagnosedcases not taking any medicines for last 3 months) by assessing Subjectiveparameters, Fasting and Post Prandial blood sugar level (FBS and PPBS) andUrine Sugar on Day 0, 30, 60 and 90. HbA1C will be assessed on Day 0and 90. A proforma shall beprepared incorporating the grading criteria for above mentioned parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed for the first time or Diagnosed cases not taking any medicine for 3 last months.
- •Patients with cardinal symptoms of Madhumeha described in Ayurveda classics.
- •Patients having F.B.S. in the range of 126 – 200 mg/dl and/or P.P.B.S. between 180-300 mg/dl will be selected for the study.
- •Patients willing and able to provide signed ICF prior to study will be included in the study.
排除标准
- •Patient with type 1 Diabetes mellitus.
- •Patients with type 2 Diabetes mellitus who are on insulin or oral hypoglycemic drugs.
- •Patients with FBS ≥ 200 mg/dl and/or PPBS ≥ 300 mg/dl.
- •Patients of Gestational Diabetes and Juvenile Diabetes.
- •Patient having Type-II DM with any other serious systemic disease.
- •Patients with complications like cardiac disorder, diabetic foot, Nephropathy and other secondary complications.
- •Individuals participating in any other clinical trial.
- •Pregnant or lactating females.
结局指标
主要结局
Changes in FBS
时间窗: 90 Days
次要结局
- Changes in Subjective parameters, PPBS, HbA1c and Urine Sugar(90 Days)